Thermo Fisher Scientific · 1 day ago
Clinical Research Associate (Level II) - FSP Oncology - California/Nevada
Carlsbad, CA
Full-time
Onsite
New Grad, Entry, Mid Level
$67K/yr - $122K/yr
0+ years expThermo Fisher Scientific is a global leader in scientific services, dedicated to making the world healthier, cleaner, and safer. The Clinical Research Associate (Level II) will be responsible for monitoring clinical trial sites, ensuring compliance with protocols, and facilitating communication between various stakeholders to support clinical research activities.
Research
Responsibilities
Monitors investigator sites with a risk-based monitoring approach; applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable
Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials
Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System)
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts
Responds to company, client and applicable regulatory requirements/audits/inspections
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner
Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members
Contributes to other project work and initiatives for process improvement, as required
Qualification
Required
Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 Months - 2 years as traveling clinical research associate)
Valid driver's license where applicable
Proven clinical monitoring skills
Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
Good organizational and time management skills
Effective interpersonal skills
Attention to detail
Ability to remain flexible and adaptable in a wide range of scenarios
Ability to work in a team or independently as required
Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Good presentation skills
Benefits
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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